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The NOrdic-Baltic Randomized Registry Study for Evaluation of PCI in Chronic Total Coronary Occlusion (NOBLE-CTO)

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ClinicalTrials.gov Identifier: NCT03392415
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : June 28, 2018
Sponsor:
Information provided by (Responsible Party):
Leif Thuesen, Aalborg University Hospital

Brief Summary:
Randomized registry for the study of CTO PCI as adjunction to optimal medical therapy.

Condition or disease Intervention/treatment Phase
Chronic Total Occlusion of Coronary Artery Heart Failure Angina Pectoris Procedure: CTO PCI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized registry with option of crossover after 6months
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The NOrdic-Baltic Randomized Registry Study for Long-term Clinical Evaluation of Adjunction of PCI to Optimal Medical Therapy in Chronic Total Coronary Occlusion
Actual Study Start Date : June 1, 2018
Estimated Primary Completion Date : October 2037
Estimated Study Completion Date : April 2038

Arm Intervention/treatment
Active Comparator: Initial conservative treatment
Optimal medical therapy and option for crossover after 6 months or fulfillment of certain conditions
Procedure: CTO PCI
attempted percutaneous coronary intervention of the chronic total coronary occlusion

Experimental: initial interventional treatment
CTO PCI attempt as initial strategy with medical optimization simultaneously
Procedure: CTO PCI
attempted percutaneous coronary intervention of the chronic total coronary occlusion




Primary Outcome Measures :
  1. All-cause mortality [ Time Frame: a minimal follow-up of 6 months ]
    All-cause mortality after inclusion of 2000 patients

  2. Quality of life assessment [ Time Frame: 6 months. ]
    Quality of life assessment by 12-Item Short Form Survey Instrument (SF-12v2)


Secondary Outcome Measures :
  1. MR perfusion [ Time Frame: 6 months ]
    Reduction of inducible myocardial perfusion defect evaluated, improvement of left ventricular function and correlation of angina and perfusion defect

  2. Echocardiography [ Time Frame: 6 months ]
    evaluation of systolic and diastolic left ventricular function compared to index echocardiography before CTO PCI.


Other Outcome Measures:
  1. Socio-economic [ Time Frame: 1 year ]
    Socio-economic consequenses of CTO PCI. Treatment cost compared to coronary bypass surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥1 CTO lesion amenable to PCI.
  • Stable and stabilized coronary artery disease
  • Symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by SPECT, PET or MR and/or angiographic/echocardiographic indication of reversible ischemia.
  • CTO lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).

Exclusion Criteria:

  • Expected survival <1 year.
  • Renal failure on dialysis.
  • Stable non-CTO lesions treated within one month.
  • Declined informed consent.
  • Regarding CMR: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392415


Contacts
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Contact: Martin K Christensen, MD +45 9766 4454 m.kirk@rn.dk
Contact: Leif Thuesen, MD +45 9766 4465 leif.thuesen@rn.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9100
Contact: Leif Thuesen, MD    +4522328264    leif.thuesen@rn.dk   
Sponsors and Collaborators
Leif Thuesen
Investigators
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Study Chair: Søren Pihlkjær Hjortshøj, MD Aalborg University Hospital
  Study Documents (Full-Text)

Documents provided by Leif Thuesen, Aalborg University Hospital:

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Responsible Party: Leif Thuesen, Senior consultant, Aalborg University Hospital
ClinicalTrials.gov Identifier: NCT03392415     History of Changes
Other Study ID Numbers: N-20170063
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: June 28, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Leif Thuesen, Aalborg University Hospital:
chronic total occlusion
CTO
PCI
percutaneus coronary intervention

Additional relevant MeSH terms:
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Heart Failure
Angina Pectoris
Coronary Occlusion
Heart Diseases
Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Coronary Disease